Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Bronchiolitis, a condition unique to the young lung, is the leading cause of hospitalization for viral lower respiratory tract infections (LRTI) in 0–2-year-old children, including those born preterm. There are critical knowledge gaps in defining the condition, predicting its severity, and understanding the reasons for hospitalization, including the immature host respiratory immune response to viral infection, heterogeneity in response to different viruses, current interventions, practice variation in diagnosis and management, and subsequent long-term impact on lung health. To address these needs and begin to move toward precision-based therapies, the Viral Infections in the Young Lung (VINYL) Consortium will conduct a deep phenotyping study of 1500 0-2 year old participants hospitalized in the United States with viral LRTI – bronchiolitis, pneumonia and/or Pediatric Acute Respiratory Distress Syndrome (PARDS), collect data and biospecimens to build a multidimensional database of this cohort that will be followed longitudinally until the age of 4–5 years, and thus elucidate the pathobiology and impact of early hospitalization for viral LRTI on lung and airways health at pre-school age. This will create the largest multidimensional and publicly accessible database to characterize this unique population and elucidate mechanisms and heterogeneity of host responses to Viral Infections in the Young Lung.

Purpose and Objectives

The purpose of the VINYL initiative is to establish a cooperative consortium funded for up to seven years under the UG3/UH3 phased award for a Clinical Coordinating Center (CCC, RFA-HL-26-006) and a companion U24 award for a Data and Analytics Coordinating Center (DACC). This NOFO seeks applications to support the Data and Analytics Coordinating Center (DACC) that will facilitate site activation, harmonization of research activities, and uniform data collection and ingestion across all centers and sites, in order to build a live publicly accessible database. Further, the DACC will assist the Clinical Coordinating Center (CCC) and Clinical Centers (CCs) in cohort retention, remote and in-person follow-up activities, incorporating the inventory of the Biorepository into the database, and facilitating acquisition of biospecimens by providing links for applicants to apply to the Biorepository for issue of biospecimens. The VINYL Consortium will bring together five CCs (each made up of one main site and 1-3 optional sub-sites, funded under the companion RFA-HL-26-006) led by the CCC - which also serves as one of the CCs - to form a cooperative research platform. The platform will include the Consortium-wide longitudinal cohort study with deep phenotyping of participants at the time of enrollment (hospitalization), and facilitate mechanistic studies, focused on viral respiratory infections in young children between 0–2 years of age. The VINYL Consortium DACC will be supported by project scientists from the NHLBI and other Institutes and Centers (ICs) at NIH as needed, a NHLBI statistician as well as an NHLBI-appointed independent Observational and Data and Safety Monitoring Board (DSMB). In addition, NHLBI will assemble a research advisory board comprised of multidisciplinary experts: the VINYL Advisory Board (VAB).

It is anticipated that each CC will enroll at least 300 participants over years 2, 3 and 4 of the award for a total of 1500 participants. Enrollment of participants early in their hospital course is encouraged. Participants will be followed longitudinally with an evaluation at 6 months post-discharge and retention of the cohort with follow-up, remote or in-person. An in-person visit is required at age 4–5 years.

The Consortium-wide longitudinal cohort study (including deep phenotyping to characterize the cohort at the time of enrollment) protocol will be determined by a Steering Committee comprised of the CCC Principal investigator (PI)(s), CC Investigators, Biorepository co-investigator (when applicable), DACC PI(s), a Steering Committee Chair (appointed by NHLBI), NHLBI statistician and NIH program staff during the first year of the program. The Steering Committee will lead all protocol development and review enrollment and study conduct, applications for ancillary studies, publications and oversight of the policies and procedures throughout the duration of the study. Hypothesis-driven scientific questions during the hospital and post-hospital period may be assessed through data, imaging, and/or biospecimens collected through the Consortium-wide longitudinal cohort study protocol. The Consortium seeks to answer questions such as:

1. Why do young children have such severe disease? Why are babies born preterm at higher risk?
2. What are the immune underpinnings of severe LRTI in this age group?
3. What are the prognostic indicators of clinical outcome-phenotypes and endotypes?
4. What clinical interventions are effective and in which subgroups?
5. How can those that are at risk for long term lung disease be identified?

Throughout the program’s funding period, data (including imaging data) and biospecimens that are collected will be made available as a resource to the broader research community as rapidly as possible with processes for data sharing that are simple and achievable. Data and biospecimens will be collected with forward-looking data sharing policies compatible with broad consent to enable future research studies by others, both within and outside the Consortium. The process for sharing data and biospecimens throughout the program’s funding period with the broader research community will be developed in the first 6 months, consistent with NHLBI policies for deposition into NHLBI BioData Catalyst and BioLINCC. Data and biospecimens are expected to be shared as rapidly as possible, with an estimate of the frequency of uploads (e.g., every 6 months or every year) provided in the application. Wherever possible, the consortium will not hold data or biospecimens for its exclusive use or for the exclusive use of one of its components and will endeavor to make samples (including information about how the samples were obtained and processed) and data, available to the broader research community. In accordance with data and biospecimen policies set up within the first 6 months of the program, data will be deposited into NHLBI’s repositories (anticipated to be BioData Catalyst) and made available for use by the research community annually and at the end of the program. All biospecimens will be deposited into NHLBI's repository (anticipated to be BioLINCC) and made available for continued use by the research community at the end of the program

Program Structure

It is anticipated that the VINYL Consortium will consist of one DACC (funded through this NOFO), and a CCC (which will include one of the five CCs and one Biorepository) funded through the companion NOFO (RFA-HL-26-006), which will include five CCs and one Biorepository, as well as a Steering Committee, an advisory board and program staff from the NHLBI and other ICs as indicated. The VINYL Consortium participants will be expected to collaborate in an interactive manner, develop and implement a consortium-wide deep phenotyping at enrollment and longitudinal cohort study, and share data (including imaging data) and biospecimens collected throughout the program's funding period with researchers within and outside the VINYL Consortium.

The first year of funding for the DACC under this NOFO will correspond to the UG3 phase of the companion UG3/UH3 CCC application (see RFA-HL-26-006). During the first year, the DACC will develop study partnerships, finalize the protocol and obtain approvals from the Data Safety and Monitoring Board and Institutional Review Board (s), establish data and project management systems and plans, and establish the web-based platform. The DACC will collaborate with the CCC and CCs to coordinate, administer, and support all VINYL Consortium administrative, governance, regulatory, analysis, reporting, dissemination, and data/biospecimen sharing activities. The DACC Principal Investigator(s) is (are) expected to share in the scientific leadership of the VINYL Consortium by participation in the Steering Committee. The DACC will be expected to have expertise in statistics, longitudinal cohort studies, informatics, data management (including imaging data), and biospecimen data management, and to have demonstrable interest in developing proactive policies for data sharing. The DACC is expected to provide the methodological, analytical, managerial, website, computer systems, logistical, and administrative expertise to support research and operational activities of the VINYL Consortium including, but not limited to : (1) collaborating in the design and analytic plans for the Consortium-wide longitudinal cohort protocol to be executed by all CCs; (2) manage the DACC protocol budget; (3) provide support that is flexible to enable operation and administrative activities; (4) manage and evaluate data quality and integrity, harmonize data ingestion, and provide relevant reports to the Steering Committee and DSMB; (5) provide assistance as needed for the mechanistic human studies; (6) monitor and evaluate consortium-wide longitudinal cohort protocol execution and subject accrual, and provide relevant reports to NHLBI staff, the Steering Committee and the DSMB; (7) develop procedures for quality control, training and certification, case report forms, data management, and regulatory compliance; (8) provide logistical support for meetings (in-person or virtual) and video/teleconferences of the Steering Committee and its subcommittees, and the DSMB; (9) provide support for preparing and submitting collaborative presentations and manuscripts; (10) provide support for statistical and data analyses; (11) storage, maintenance, and analysis of data (including imaging data) and biospecimens as needed for the Consortium-wide protocol; (12) oversee and facilitate data (including imaging data) and biospecimen sharing among CCs and investigators outside the Consortium; (13) create and maintain an outward facing website that is updated regularly and includes study documents (e.g., Consortium-wide protocol, informed consent forms) and information about available data and biospecimens and the process for requesting data and biospecimens during the VINYL Consortium funding period; (14) transfer data, imaging, and biospecimens to NHLBI's repositories annually (for data) and ensure that all data and biospecimens are available in NHLBI repositories at the conclusion of the program; (15) oversee a Skills Development Core that will provide skills development opportunities in the conduct of research in young hospitalized children, and the collation of data to create a live publicly accessible database contributing to the development of the next generation of researchers in clinical research and bioinformatics; (16) utilize the capabilities of the CCs to the maximum benefit of the entire Consortium; and (17) track progress of publications, and presentations of findings. Additional details regarding these areas of responsibility are described below.

Consortium-wide Deep Phenotyping at Enrollment and Longitudinal Cohort Study Protocol Development, Study Design, and Analysis

The DACC will lend study design, statistical and biomedical scientific writing expertise to the protocol development team, including assisting in the determination of study endpoints and analytical approaches and assisting in refining common data elements, the use of which are encouraged. Facilitation of protocol development meetings/teleconferences to ensure that the protocol is developed and executed within specified VINYL Consortium timelines, and review of the Consortium-wide longitudinal cohort study protocol through the Steering Committee, DSMB and other processes will be performed by the DACC. The DACC will provide documentation and categorization expertise to the Biorepository within the Clinical Coordinating Center. It is anticipated that the biospecimens collected and processing methods under the common protocol may include, but are not limited to, blood, urine, and lung specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage fluid), and that chest X-ray or other medical images using novel imaging systems will be collected. DACC applications should plan for coordinating the prospective enrollment of 1500 U.S. 0-2 year old participants overall (anticipated to be enrolled during years 2, 3, and 4 of the award) and cohort retention plans until they reach the age of 4–5 years. This timeline is intended to provide adequate time for protocol development during the first 6-9 months of Year 1 support, enrollment and follow-up, completion of data analysis and manuscript preparation by the end of Year 7.

Data Management and Analysis

Development, maintenance, and/or refinement of data dictionaries and a 21CRF Part 11-compliant electronic data capture (EDC) system for studies conducted by the VINYL Consortium, assuring high data quality through edit/validation checks, serving as a central repository for study data including imaging data during the Consortium lifetime are DACC responsibilities. Additional DACC responsibilities are expected to include oversight of secure data storage, secure transfer of study-generated data, and coordinating applications for issue of biospecimens from the Biorepository. The DACC will be responsible for preparing confidential data analyses and providing reports as requested by the NHLBI, the Steering Committee, the VINYL Advisory Board, the DSMB, and regulatory agencies. The DACC will also be tasked to coordinate data analysis, reporting, and publishing of VINYL Consortium research in high-quality peer-reviewed journals, as they relate to the Consortium-wide longitudinal cohort study protocol and the mechanistic studies proposed by the CCC. 

Data and Biospecimen Sharing

The following duties will be performed by the DACC

• Development of a plan to make data (including imaging data) and biospecimens collected through the Consortium-wide longitudinal study available to CC investigators for CC-specific projects as rapidly as possible
• Development of a plan to make data and biospecimens collected through the Consortium-wide longitudinal study available as a resource to the broader research community as rapidly as possible. Data and biospecimens will be collected with forward-looking data sharing policies compatible with broad consent to enable future research studies by others, within and outside the Consortium. Development of a process for sharing clinical and research data (including imaging) and biospecimens throughout the program’s funding period with the broader research community during the first year of the program, with input and approval from NIH staff will be expected
• Creation and maintenance of an outward facing website that is updated regularly and includes information about available data and biospecimens and the process for requesting data and biospecimens during the VINYL Consortium funding period. Data and biospecimens are expected to be shared as rapidly as possible, with processes that are simple and achievable. Wherever possible, the consortium will not hold data or biospecimens for its exclusive use or for the exclusive use of one of its components, and will endeavor to make samples (including information about how the samples were obtained and processed) and data available to the broader research community. In accordance with data and biospecimen policies set up within the first 6 months of the program, data will be deposited into NHLBI’s repositories (anticipated to be BioData Catalyst) and made available for use by the research community annually and at the end of the program. Biospecimens will be deposited into NHLBI's repository (anticipated to be BioLINCC) and made available for continued use by the research community at the end of the program
• The NHLBI anticipates the DACC will prepare, distribute for review, finalize, and then disseminate the approved protocol, protocol amendments, manual of procedures, and other materials necessary for conduct of the Consortium-wide study.

Skills Development Core

The DACC will direct and coordinate skills development core activities that will contribute to the development of the next generation of physician scientists and data scientists  in the VINYL consortium.

The NHLBI encourages multi-PD/PI applications with at least two PD(s)/PI(s); one a senior statistician with demonstrated experience in coordinating large multi-site clinical research studies and another senior investigator with epidemiology and human subject research experience. Familiarity with and support for data and biospecimen collection for sharing purposes is desirable. Applications for the DACC may be submitted by individuals at the same institution as the CCC application, but a single individual may not be the PI on both the CCC and DACC applications.

NIH:

NHLBI will be responsible for overall support, direction and oversight of the VINYL Consortium. The NHLBI Program Office and Office of Grants Management will oversee the overall direction and progress of the VINYL Consortium. In addition to regular grant stewardship, the NHLBI Program Officer and Project Scientist (envisioned to be the same individual) will be involved substantially with the awardees as one voting member of the Steering Committee, consistent with the Cooperative Agreement mechanism. The NHLBI will appoint an independent DSMB, Steering Committee chair and an independent Advisory Board to the Institute and the VINYL investigators. Representatives from other ICs may participate as needed as non-voting members of the Steering Committee and will provide input to the NHLBI representative, when indicated, on items presented to the Steering Committee for a vote.

Steering Committee:

A Steering Committee composed of the principal investigators of the CCC and co-investigator of the Biorepository (if applicable), the DACC, CC investigators, a Steering Committee chair appointed by NHLBI, and NHLBI and other IC representatives will form the core governing body of the VINYL Consortium. All major scientific decisions will be determined by majority vote of the Steering Committee. The CCC, Biorepository co-investigator, each CC (independent of multiple PIs), the DACC, and the NHLBI will have one vote each; the Steering Committee chair will have a vote in case of a tie vote among the other Steering Committee members. It is anticipated that the Steering Committee will meet once a month by conference call and by in-person meeting once a year (with virtual meetings as an option/alternative if necessary). The Steering Committee has primary responsibility for the general organization of the VINYL Consortium, approval of the Consortium-wide longitudinal cohort study protocol and budget, including protocol revisions, before review by the DSMB, the conduct and monitoring of VINYL Consortium studies, the expeditious reporting of study results, and the rapid sharing agreements for VINYL consortium data and biospecimens. Subcommittees of the Steering Committee will be established to oversee specific functions such as protocol development and oversight, ancillary studies, publications, biorepository, and data and biospecimen sharing. The Steering Committee will monitor disclosures of financial interests and potential conflicts of interest among investigators, but such monitoring will not preclude investigators’ responsibility to report their financial disclosures to their respective recipient institutions. Recipient members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

During the first 6-9 months of the U24 award to the DACC, which matches the UG3 award year (Year 1 of the companion award to the CCC), the Steering Committee (in conjunction with the CCC and with assistance from the DACC) will be responsible for developing the consortium-wide longitudinal cohort protocol that outlines standardized procedures for enrolling participants and procedures and methods for the collection of data, images, and biospecimens across all participating sites within the VINYL Consortium. It is expected that the Consortium-wide protocol may be refined iteratively over the course of the project period as new data become available. The protocol, and any subsequent changes to that protocol, in the observational component, the peer-reviewed mechanistic studies (BESH) and the longitudinal and follow-up evaluation will be voted on and must be approved by majority vote of the Steering Committee to be implemented. In addition, NHLBI will appoint an independent expert advisory board to the VINYL consortium, the VINYL Advisory Board (VAB) that may be consulted for opinions and advice. The Advisory Board will comprise a chairperson, clinicians, and scientists with expertise in infectious diseases, viral immunology, airways disease, pediatric hospital and critical medicine and pulmonology, observational study design, outcome measures, biostatistics, ethics, biospecimen collection, and other areas of expertise as needed. The Advisory Board will evaluate scientific merit, experimental design and approach, feasibility, appropriateness in the context of the VINYL Consortium program goals, and consistency with NHLBI’s mission and policies.

VINYL Advisory Board (VAB)

An independent VINYL Advisory Board (VAB) will be appointed by and be advisory to the NHLBI. It will consist of a chairperson, clinicians, and scientists who are recognized as experts in viral infections in the young lung, immunology, infectious diseases, cell biology, molecular biology, observational study design, outcome measures, biostatistics, ethics, biospecimen collection, and other areas of expertise as needed. This Board may be consulted for independent advice on any aspect of the underlying science, the relevance and significance of research questions, clinical monitoring, human subject protection, policies and procedures, analysis of outcomes, and data analytics while building the VINYL consortium.

Observational Study and Data and Safety Management Board

An independent Observational and Data and Safety Monitoring Board (DSMB) will be appointed by and advisory to the NHLBI. The DSMB will be responsible for providing independent advice to the NHLBI regarding study safety and related ethical considerations, the observational deep phenotyping study, the longitudinal cohort study, the progress of the basic experimental studies in humans (BESH), and the appropriateness of continuing the studies performed by the VINYL Consortium. The DSMB will also review and, if deemed appropriate, concur with the implementation of the consortium-wide protocol and associated studies. The DSMB will meet approximately every six months, with interim meetings as necessary. The DSMB will be compensated by the DACC. The DACC will be responsible for the timely provision of Reports to the DSMB and scheduling the meetings.

Human Subjects Protection

Regulatory Affairs and Compliance

Assuring compliance with the Health Insurance Portability and Accountability Act (HIPAA) within the VINYL Consortium in accordance with 45 CFR Parts 160, 162, and 164; Implementation and supervision of the revised Common Rule (45 Part 46) within the VINYL Consortium, including the use of a single-IRB review for federally funded, multi-institutional studies conducted in the United States are required. Clinical Centers must agree to use of the single Institutional Review Board (sIRB) selected by the Coordinating Center for all VINYL Consortium studies, consistent with NIH policies regarding multi-site studies involving human subjects.

Responsiveness to this NOFO
 

NHLBI will accept applications that include Basic Experimental Studies in Humans (BESH) - mechanistic human studies, with prospective interventions to elucidate pathobiology. In accordance with NOT-HL-19-690, for applications that propose Clinical Trials, NHLBI will accept applications that propose the following:

• Mechanistic studies that meet NIH’s definition of a clinical trial and that have the primary goal of understanding how an intervention works. Mechanistic studies are designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (the goal must not be to evaluate safety, pharmacokinetics or pharmacodynamics, efficacy, or clinical trial feasibility).
• Fundamental or basic experimental studies involving humans (BESH) that do not have specific processes or products in mind.
• Hybrid applications, i.e., applications that propose non-interventional fundamental science aims along with the mechanistic or BESH clinical trial(s)
• Studies using surrogate or clinical outcomes for the purpose of providing preliminary proof of an expected effect (these must not be efficacy studies, see next section) of the proposed mechanistic and fundamental or basic experimental study 

The following types of applications will be considered non-responsive to this NOFO and will be returned without review:

• Applications that propose to enroll participants hospitalized outside the United States
• Applications that propose to conduct preclinical studies involving vertebrate animals

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Foreign Organizations/ International Collaborations

NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

NHLBI encourages multi-PD/PI applications with at least two PDs/PIs; one with biostatistical expertise and demonstrated experience in coordinating large multi-site clinical research studies, and another senior investigator with extensive clinical research experience and expertise in the areas of pediatric observational and longitudinal studies. Familiarity with and support for data and biospecimen collection for sharing purposes is desirable.   
 

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

CCC and DACC applications will be submitted as companion applications with the same submission and review dates.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

The PD/PI (or Multi-PDs/PIs) of the DACC must be experienced in the coordination and management of a multi-center research project, including success in meeting milestones and timelines. The experience of each PD/PI and all Key Personnel must be carefully documented and roles and responsibilities must be well-defined. DACCs require a multidisciplinary team and the application should reflect the team's hands-on involvement in DACC functions, including coordination, tracking, logistics and administration, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure study websites), regulatory support, and biostatistical/analytical support. The DACC application must include personnel and corresponding biographical sketches for the DACC only. All Key Personnel who are major scientific contributors to the study must provide an NIH Biosketch whether or not they are budgeted. The PD/PI (or Multi-PDs/PIs) for the DACC cannot be Key Personnel on the CCC application. 

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

The application must include only its own budget, including any subcontract budgets associated with it. Separate itemized budgets must be prepared for each subcontract. The application must provide detailed annual budgets that will enable the DACC to meet its milestones.

All costs requested and all changes in budgets after the first year should be clearly identified and justified. The DACC budget must be synchronized with the CCC budget.

The DACC should include in their budget all costs associated with DSMB activities. This includes the costs for preparing reports for the DSMB and meeting reimbursement for the DSMB members. The DACC should assess the need for liability insurance for DSMB members and provide a plan commensurate with the risk of the study. The budget should include provision for executing the plan proposed. The DACC should also include a plan for assessing DSMB member conflict of interest, and put associated costs in the budget. Additionally, if the DSMB is convened by NHLBI, the DACC should include in their budget coordination of support for at least one DSMB meeting per year in Bethesda, MD and coordinate regular DSMB calls as needed (by teleconference or videoconference).

Include budget support for steering committee meetings whether in person or as a hybrid video conference. Include budget support for publication, dissemination of results, and data sharing.

In addition, budget support for an independent study chairperson should be included.

The DACC budget should request only the costs that will be required for the activities to be performed in a given year. 

It is recommended that at least a cumulative a minimum of 4.8 person-months among the PD(s)/PI(s) be included. Person months for other Investigators/Staff, the person-months should be commensurate with the effort required for the proposed personnel activities. This should include biostatistical support staff with demonstrated experience in the oversight of large clinical research studies to manage the Coordinating Center's day-to-day activities involving data management and statistical analysis; a comprehensive knowledge of GCP study conduct; development of study enrollment accrual benchmarks.

It is suggested that the Budget adequately address the following:

• Expenses related to the development and implementation of the Consortium-wide protocol, including use of established Common Data Elements; methods for timely safety monitoring and reporting of adverse events to the appropriate entities, study monitoring reports to track patient accrual, follow-up rates, adherence to protocol, and data quality. Applicants should assume that each Clinical Center (with 1–3 subsites (optional)) will enroll 300 U.S. participants each over 3 years into the Consortium-wide protocol beginning in Year 1 through Year 3-4 of the project period (i.e., 1500 total U.S. participants).
• Expenses related to managing the DSMB to include remuneration for services provided and travel expenses for approximately five members to attend a one-day meeting occurring in-person in Bethesda, Maryland, during the first year and additional meetings by conference call on an as-needed basis but no less frequently than every 6 months thereafter.
• Expenses related to managing the Advisory Board to include travel expenses for approximately five members to attend one meeting occurring in-person in Bethesda, Maryland, during the first year and additional meetings on an as-needed basis by conference call.
• Site monitoring activities that will be conducted via centralized monitoring to the extent possible, but provisions for site visits to improve training and site performance as needed.
• Expenses associated with creating and maintaining an outward facing website that includes information about available data (including imaging data) and biospecimens and the process for requesting data and biospecimens, data/biospecimen request review meeting costs, data transfer costs etc.
• Expenses associated with providing statistical support to the Clinical Centers and analysis of aggregate Consortium-wide protocol data, including the development and maintenance of systems for data entry, transmission, quality control, and analytics.
• Expenses associated with the creation and maintenance of a secure data access portal with project management dashboards to coordinate efficient workflow, assessment of progress, and enable open access of study data to VINYL Consortium investigators, as well as related costs to ensure compliance with the NIH Data Management and Sharing Policy.
• Expenses associated with creation and maintenance of a secure portal for imaging data, including plans for managing imaging data deposition, tracking, access, and sharing.
• Costs related to the design and maintenance of the VINYL Consortium website.
• Costs to engage a sIRB for all VINYL Consortium studies.
• Applications must plan for direct costs for skills development activities each year. Allowable costs include salary support for the Skills Development Core director and other senior investigators and staff participating in mentoring activities; travel costs for junior investigators; supplies and equipment to support developmental activities; and costs for courses, seminars, workshops, and other activities directly related to the VINYL Consortium Skills Development Core. All costs requested should be justified with respect to developmental activities and may not be used to supplement the costs of research proposed in the rest of the VINYL Consortium application. Salary support for the junior investigators is neither needed nor allowable, since the VINYL Consortium Skills Development Core is intended to serve new clinical investigators who occupy positions and receive salary support from other sources.
• Other expenses related to Data and Analytic Coordinating Center core activities as appropriate.
   

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

The research strategy must describe the following:

Plans for leading and coordinating a complex multi-center observational study of patients 0-2 years of age, hospitalized with viral bronchiolitis, pneumonia or pediatric ARDS (PARDS) and in-person follow-up at 6 months post-hospitalization. Include plans for maintenance of cohort employing in-person and remote methods until age 4-5 years. 

• Plans for data and biospecimen collection and organization for proactive sharing for future research purposes beyond the VINYL Consortium.
• Discuss experience with prior relevant studies as a means of justifying the proposed approach to overseeing the design and conduct of a multi-center observational study for data collection, ways to maximize recruitment and retention, and minimize logistical, operational, and regulatory issues. Include a description of novel approaches to enhance data collection and organization, analysis, and dissemination in order to maximize scientific output from the VINYL Consortium. Include the plan for the living database with processes and procedures clearly described with timelines, data security and novel modern methods of data ingestion and sharing.
• Discuss the approach to operations management by providing evidence of data management and program support capabilities and describing the plan for data collection, management, analysis, data security and backup, privacy protections, and quality control. The plan should include an approach to monitoring patient safety, protocol execution quality, data entry quality, and participant accrual; providing relevant reports to NHLBI, the Steering Committee and the DSMB; and training and competence certification of research staff in the Data center.
• Discuss the timeline and plans for how the DACC will cooperate and interact with the CCC and across the CCs to achieve coordination of all VINYL Consortium activities during the project period include strategies to manage and support electronic and other communications; support regulatory affairs and compliance, human subjects protections, data monitoring, clinical operations and administrative activities; inform study design; provide support for data collection, management, and statistical analysis; and reporting of results in a timely manner.
• Provisions for logistical and communications support to the CCs within the VINYL Consortium, and to the broader research and patient communities. Web resources and data management systems should provide secure distribution of study documents, forms, and metrics of study progress and performance. Plans should also include an open-access website that communicates information about the VINYL Consortium to the public, prospective research participants, and the broader research community.
• Without duplicating information in the Data Management and Sharing Plan, describe plans to share data (including imaging data) throughout the funding period with the broader research community, plans to work with the co-investigator of the Biorepository to facilitate applications for and distribution of biospecimens, including plans for inclusion of forward-looking data sharing policies compatible with broad consent, processes to allow sharing as rapidly as possible, and plans for an outward facing website that includes information about available data and biospecimens and the process for requesting data and biospecimens.
• Describe plans for facilitating efficient review and approval of the study by the Steering Committee and DSMB. Applicants should assume that each awarded Clinical Center will enroll 100 U.S. participants annually for three years into the Consortium-wide protocol. It is anticipated that the biospecimens collected under the protocol may include, but are not limited to, blood, urine, and lung samples (e.g., sputum, tracheal aspirate, bronchoalveolar lavage fluid) as well as radiographic or other medical images, and the applicant should discuss special considerations for the documentation and data ingestion of results from the analyses of these specimens. These plans should also include how the DACC plans to facilitate a timeline that includes protocol development in year 1, enrollment and follow up through Years 5 and 6, collation and analysis over 7 years. 
• Plans for directing and coordinating Skills Development Core activities. The Skills Development Core is intended to foster the next generation of researchers at the VINYL Consortium sites, including fellows and junior faculty members at the interface of clinical research and bioinformatics. Include a plan for skill development of junior investigators (including didactic preparation) that will promote progress to more independent research status, the nature and extent of mentoring. A plan for coordinating partnership and collaborations with professional societies or foundations is encouraged.
• Provide an overview of the overall organization of personnel in the proposed DACC’s research team and describe the ability and commitment of the investigators to function as a coordinated research team, to work efficiently and expeditiously with, and to enhance the research goals of the VINYL Consortium. A sound rationale should be provided as to why the research team is the most appropriate, and likely to generate an exceptionally high impact protocol and maximize scientific output/study results from the consortium if successful. Provide an overview of the Coordinating Center team member roles and responsibilities. Describe how the research team is poised to provide scientific leadership and scholarship to the VINYL Consortium through collaboration with the Clinical Centers, the Steering Committee, and NIH partners.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

All applications, regardless of the amount of direct costs requested for any one year, should address a Resources Sharing Plan. 

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• Data Management and Sharing Plans should comply with the guidelines and requirements set forth in NOT-OD-21-013 and related Notices that establish the NIH-wide Data Management and Sharing Policy. Data Management and Sharing Plans that do not conform to these requirements will not be considered adequate. This plan should be as forward-looking and proactive as possible to rapidly share data (including imaging data) and biospecimens collected in the VINYL Consortium, as well as materials and methods, in order to enable future research studies by the broader research community.
• Data will be deposited into NHLBI’s repositories (anticipated to be Biodata Catalyst and BioLINCC) and made available for use by the research community as soon as possible, minimally annually, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NHLBI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The DACC is expected to provide the methodological, analytical, managerial, website, computer systems, logistical, and administrative expertise to support research and operational activities of the VINYL Consortium including, but not limited to : (1) collaborating in the design and analytic plans for the Consortium-wide longitudinal cohort protocol to be executed by all CCs; (2) manage the DACC protocol budget; (3) provide operation and administrative support; (4) manage and evaluate data quality and integrity, harmonize data ingestion, and provide relevant reports to the Steering Committee and Data and Safety Monitoring Board (DSMB); (5) provide assistance as needed for the mechanistic human studies; (6) monitor and evaluate consortium-wide longitudinal cohort protocol execution and subject accrual, and provide relevant reports to NHLBI staff, the Steering Committee and the DSMB; (7) develop procedures for quality control, training and certification, case report forms, data management, and regulatory compliance; (8) provide logistical support for meetings (in-person or virtual) and video/teleconferences of the Steering Committee and its subcommittees, and the DSMB; (9) provide support for preparing and submitting collaborative presentations and manuscripts; (10) provide support for statistical and data analyses; (11) storage, maintenance, and analysis of data (including imaging data) and biospecimens as needed for the Consortium-wide protocol; (12) oversee and facilitate data (including imaging data) and biospecimen sharing among CCs and investigators outside the Consortium; (13) create and maintain an outward facing website that is updated regularly and includes study documents (e.g., Consortium-wide protocol, informed consent forms) and information about available data and biospecimens and the process for requesting data and biospecimens during the VINYL Consortium funding period; (14) transfer data, imaging, and biospecimens to NHLBI's repositories annually (for data) and ensure that all data and biospecimens are available in NHLBI repositories at the conclusion of the program; (15) oversee a Skills Development Core that will provide skills development opportunities in the conduct of research in young hospitalized children, and the collation of data to create a live public access database contributing to the development of the next generation of researchers in clinical research and bioinformatics; (16) utilize the capabilities of the CCs to the maximum benefit of the entire Consortium; and (17) track progress of publications, and presentations of findings.
• Data will be deposited into NHLBI’s repositories (anticipated to be BioData Catalyst) and made available for use by the research community annually and at the end of the program.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NHLBI will be responsible for overall support, direction and oversight of the VINYL Consortium. The NHLBI Program Office and Office of Grants Management will oversee the overall direction and progress of the VINYL Consortium. The VINYL Consortium DACC will be supported by project scientists from the NHLBI and other Institutes and Centers (ICs) at NIH as needed, a NHLBI statistician as well as an NHLBI-appointed independent Observational and Data and Safety Monitoring Board (DSMB).

The NHLBI Project Scientist will serve on the Steering Committee and other study committees, when appropriate, as the voting member representing NIH. All NIH staff members share one vote in support of the project. The NHLBI Project Scientist may work with recipients on issues coming before the Steering Committee such as recruitment, protocol development, follow-up, quality control, adherence to protocol, possible changes to the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and of solutions to major problems, such as insufficient participant enrollment. An independent Chair of the Steering Committee will be appointed by the NHLBI without any other roles or responsibilities within the study.
 
The NHLBI Project Scientist will serve a dual role as the NHLBI Program Official, will be responsible for the normal program stewardship of the cooperative agreement, and will be named in the Notice of Award. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist/Program Official. The responsibility for final decision-making may reside with Senior Institute management, separate organizational components and/or oversight committees. Because it is anticipated that the Program Official will participate in activities that rise to a level of involvement (i.e., additional role as Project Scientist) that results in conflicts of interest, for example, co-publication, other staff members such as direct line supervisors and/or other Senior NHLBI Program management staff will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award. The NHLBI policy on authorship and manuscript review of NHLBI sponsored extramural research protects against conflicts of interest with the Program Official.

An independent Data and Safety Monitoring Board (DSMB) will be established to oversee participant safety in the clinical trial and provide overall monitoring of interim data and safety issues. As part of the collaborative activities under this cooperative agreement, the NHLBI will collaborate with the recipients to appoint and/or agree upon a single DSMB for monitoring the clinical trial. The DSMB may be appointed by the NHLBI, or with the approval of NHLBI, the DSMB could be an institutional DSMB. At the first meeting in the UG3 phase, the DSMB will review the recipient’s protocol and potentially recommend modifications. Subsequently, the DSMB will monitor and review recruitment, adverse events, data quality, outcome data, and overall recipient performance. The DSMB has the responsibility to review interim data and final data, and recommend whether the protocol should be modified, and, at each meeting, whether the study should be continued or should be terminated early. An NHLBI scientist other than the NHLBI Project Scientist/Program Official will serve as Executive Secretary to the Board. Because the DSMB serves as an independent group advisory to the NHLBI, study investigators shall not communicate with DSMB members regarding study issues, except as authorized by the Board’s Executive Secretary.

NHLBI will also appoint an Advisory Board comprised of independent experts in the field to advise the VINYL Advisory Board for scientific direction and advice. It will consist of a chairperson, clinicians, and scientists who are recognized as experts in viral infections in the young lung, immunology, infectious diseases, cell biology, molecular biology, observational study design, outcome measures, biostatistics, ethics, biospecimen collection, and other areas of expertise as needed. This Board may be consulted for independent advice on any aspect of the underlying science, the relevance and significance of research questions, clinical monitoring, human subject protection, policies and procedures, analysis of outcomes, and data analytics while building the VINYL consortium.

The NHLBI reserves the right to phase-out or curtail the study (or an individual award) in the event of: (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in subject recruitment milestones, core milestones mutually agreed upon by the recipient organization and PD/PI and the NHLBI, consortium participation and collaboration with other recipients, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or results that substantially diminish the scientific value of study continuation.

Areas of Joint Responsibility include:

• A Steering Committee composed of the principal investigators of the CCC and co-investigator of the Biorepository (if applicable), the DACC, CC investigators, a Steering Committee chair appointed by NHLBI, and NHLBI and other IC representatives will form the core governing body of the VINYL Consortium. All major scientific decisions will be determined by majority vote of the Steering Committee. The CCC, Biorepository co-investigator, each CC (independent of multiple PIs), the DACC, and the NHLBI will have one vote each; the Steering Committee chair will have a vote in case of a tie vote among the other Steering Committee members. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

The creation of the Publicly Accessible VINYL database is the responsibility of the DACC.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Marrah Lachowicz-Scroggins, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8229
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Email: [email protected]
Subject: RFA-HL-26-008

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.